Food Safety Modernization Act

A Reference Resource List

Compiled by Emerson Library Staff

2011

2011 Journal Citations:

FDA holds comprehensive meeting to discuss FSMA implementation. (2011, June 13). Food Institute Report, 84 (23), 1, 9-11.

This article highlights the public meeting held by the FDA on June 6 concerning the implementation of the FDA Food Safety Modernization Act (FSMA) inspection and compliance provisions. This article includes comments from the following breakout sessions topics: 1) Manner of Inspection in Preventive Controls Environment; 2.) Frequency and Targeting of Inspections; 3.) Enforcement Authorities 4.) Reportable Food Registry (RFR) Improvements.

Healy, A. (2011, January 21).

NCFPD could help FDA implement anti-terror provisions of the new law. Food Chemical News. 52 (44),10-11.

This article provides an overview of the food defense requirements of the Food Safety Modernization Act (FSMA), and highlights the special expertise of the National Center for Food Protection and Defense (NCFPD). NCFPD was created in 2004 as a section of the Department of Homeland Security to protect against acts of intentional food contamination. Discusses the FSMA timeline for FDA food defense regulations and guidance documents.

Huffman, J. (2011, January 28). FDA authorized to add 79% to field force over four years. Food Chemical News, 52 (45), 9.

This article corrects the misinformation circulating in the press that the FDA is expected under the FSMA to employ 18,000 inspectors over the next five years. In truth, the law's ultimate goal is to employ no fewer than 5,000 field staff by 2014. The FSMA does authorize the FDA to increase staff up to 79% over 4 years. However, the law does not have any control of the FDA's budget- which will be the ultimate deciding factor of how much additional staff the agency will be able to hire.

Huffman, J. (2011, April 1). FDA holds first meeting to discuss FSMA, focuses on import provisions. Food Chemical News, 53 (4), 1, 10-11.

On March 29, 2011 the FDA held their first public meeting on the implementation of the Food Safety Modernization Act. This meeting focused on the import safety provisions, including FSMA section 307 which requires the FDA to establish rules for accrediting third-party foreign auditors. The meeting included comments by representatives from the Center for Science in the Public Interest, American National Standards Institute, the Global Food Safety Initiative and Global G. A. P., Fresh Produce Association of the Americas, and National Fisheries Institute. Other meeting topics included: proposed standardization of auditing standards, foreign supplier verification program, import reporting and paperwork requirements, and the voluntary qualified importer program.

Murphy, J. (2011, June 3, 2011). ABA seeks FDA exemption of storage facilities from FSMA. Food Chemical News, 53 (13), 6.

The American Bakers Association (ABA) has petitioned the FDA to exempt storage facilities for finished, packaged foods from the hazard analysis and preventive controls requirements under the FSMA. Lee Sanders, ABA senior vice president of government relations and public affairs argues that the cost would be unsustainable for many facilities and the food safety benefits would be nonexistent. According to Sanders "The products held by these facilities are finished foods in their retail packages, are (by definition) not exposed to the environment, and have already been subjected to [Good Manufacturing Practices] and preventive controls throughout the process of their manufacture and packaging."

Murphy, J. (2010, December 31). Access to records among immediate changes in new food safety law. Food Chemical News, 52 (44), 1, 11-12.

This article is the first in a series by Food Chemical News which discusses the impact that the recently passed Food Safety Modernization Act (FSMA) will have on the food industry. This article addresses changes which will take effect as soon as the bill is signed by President Obama on January 4, 2011. The provisions that go into effect immediately include: FDA access to food company's records in cases of suspected adulteration; FDA mandatory recall authority; FDA authority to deny admission of imported food if facility inspection is denied; and legal protection for whistleblowers. This article gives a brief summary of the legislative activity of the final days before the bill was passed, with comments by Rep. John Dingell (D-Mich), Rep. Frank Lucas (R-Okla.), and Rep. Rosa DeLauro (D-Conn.). Includes interview with Ricardo Carvajal, attorney at Hyman, Phelps and McNamara.

Murphy, J. (2011, February 18). Advocates discuss reach of FFSMA’s new whistleblower protections. Food Chemical News. 52 (48), 10-11.

One of the provisions of the FSMA that took effect as soon as the bill was signed into law was the protection for whistleblowers. The scope of the legal protection includes safeguarding any employee that 1) provides information about product contamination to authorities, or 2) refuses to participate in actions that might lead to contamination. This article interviews Tom Devine, legal director at the Government Accountability Project concerning the impact of this provision and how effective it will be in protecting employees.

Murphy, J. (2011, January 14). Certified HACCP plans not enough under new food safety law: Acheson. Food Chemical News. 52 (43), 1, 10.

David Acheson, food safety director of Leavitt Partners discusses the unique challenges that food companies will face with the new FSMA requirements to conduct hazard analysis and develop preventive control plans. Even those companies with HACCP plans in place will need to adapt to the new FDA regulations, which are scheduled to take effect on July 4, 2012. The article lists the following examples of preventive controls, "sanitation procedures for food contact surfaces; supervisor, manager and employee hygiene training; environmental monitoring to verify the effectiveness of pathogen controls; a food allergen control program; a recall plan; current Good Manufacturing Practices; and supplier verification activities."

Murphy, J. (2011, February 4). FDA could use new mandatory recall authority as leverage in negotiations. Food Chemical News, 52 (46), 1, 9-10.

With increased authority to order mandatory recalls, the FDA will have more power when negotiating with food companies than the agency did previously. The FDA must prove reasonable probability that the products are misbranded or adulterated, and give the company a chance to respond voluntarily. This article also discusses the FDA's new power to suspend a company's registration if it meets Class 1 recall conditions.

Murphy, J. (2011, April 8). FDA officials share latest update in implementation of FSMA. Food Chemical News, 53 (5), 9.

This article discusses when implementation of FSMA can reasonably be expected to be complete, given the enormous amount of training, additional staff, and industry guidance that will be required of the FDA. Michael Landa, director of FDA's CFSAN stated, "Even if FDA meets every deadline under the newly passed FDA Food Safety Modernization Act, the revamped food safety system will not be built in three years but will take a decade to be fully functional." This article examines the challenge of enacting sector specific regulation of preventive controls, stressing the importance of industry initiative in drafting guidance documents.

Murphy, J. (2011, January 7). FDA officials talk about funding prospects. Food Chemical News. 52 (42), 1, 9.

As the FSMA takes effect, FDA officials stress the importance that proper funding will play in the efficient implementation of the bill. Health and Human Services Secretary Kathleen Sebelius held a press event to garner support for FSMA funding from Congress. With foodborne illness costs estimated at $152 billion annually- Erik Olson, food program director of the Pew Charitable Trusts states that "The costs of not implementing this law are staggering."

Murphy, J. (2011, May 20). Food companies more accountable under FSMA, Levitt warns. Food Chemical News, 53 (11), 8.

Highlights from a speech by food regulatory expert Joseph Levitt at the Grocery Manufacturers Association's Science Forum in Arlington, VA. Levitt discusses the increased accountability that food companies will face as the Food Safety Modernization Act takes effect. If FDA inspectors encounter enough problems to require a follow up inspection, the food company will be required to cover the personnel and laboratory costs. Levitt also discussed the FDA's increased authority to inspect company records, and food companies' responsibility in verifying the safety of supplier products.

Murphy, J. (2011, June 10). Inspection, compliance issues debated at third FDA public meeting. Food Chemical News, 53 (14), 6.

Highlights from the FDA Food Safety Modernization Act Public Meeting held on June 6, 2011 which focused on inspection and compliance issues. According to Mike Taylor, FDA Commissioner of Foods, "Current inspections are limited to making observations and documenting problems, but the law says FDA should approach inspections differently, focusing more on whether prevention systems are working." The FDA has designated implementation teams broken down by section. The Inspection and Compliance implementation team has designated the following key areas to be addressed: mandatory recall rules; new administrative enforcement powers; inspection frequency mandate; new inspections; facility registration; and improvements to the Reportable Food Registry. The Public Meeting held breakout sessions on FSMA's Inspection and Compliance issues: enforcement authorities; frequency and targeting of facility inspections; manner of inspections in a preventive controls environment; and improving the Reportable Food Registry. This article also discusses the debate held concerning how the FDA should qualify facilities or products as "high risk."

Murphy, J. (2011, July 1). NPA expects FDA to release new dietary ingredient guidance next week. Food Chemical News, 53 (17), 11-12.

The FSMA deadline for the FDA to publish the New Dietary Ingredient (NDI) guidance is July 3, 2011. The guidance will clarify how the FDA will define what constitutes a new dietary supplement ingredient, various technical concerns, and the elements of NDI notification. Includes an interview with Cara Welch, VP of scientific and regulatory affairs for Natural Products Association. This article also discusses the need for the FDA to establish a policy distinction between “dietary supplements and foods with dietary ingredient additives marketed as dietary supplements.”

Murphy, J. (2011, June 17). Pathogen testing, food safety plan reviews debated in FSMA comments. style="mso-bidi-font-style:normal">Food Chemical News, 53 (15), 9-10.

This article reviews the food industry's comments to the FDA's April 20 public meeting on the preventive control rules. Several food trade associations have argued that environmental monitoring should not be required for all FDA registered facilities, only those that produce ready-to-eat products. However, several consumer advocacy groups have commented on the importance of environmental sampling and finished product testing. This article also discusses whether food facilities must submit their prevention plans electronically at the time of FDA registration.

Murphy, J. (2011, May 5). PMA urges border changes as FDA builds new import program. Food Chemical News, 53 (9), 6.o:p>

The Produce Marketing Association responded to the FDA's request for comments on import requirements under the FSMA, suggesting the following improvements: 1) improved performance standards for laboratory testing methods and procedures; 2) reduced border delays through improved staffing, operational procedures, and infrastructure; and 3) maintain the FSMA deadline for the voluntary qualified importer program. PMA also questions the impact the Tester amendment will have on international produce standards.

Murphy, J. (2011, May 20). Taylor says FDA will take practical route in implementing FSMA deadlines. Food Chemical News, 53 (11), 1, 9.

The FDA Deputy Commissioner Mike Taylor addressed the Grocery Manufacturers Association's (GMA) Science Forum concerning the implementation of the Food Safety Modernization Act deadlines. Taylor pointed out that there were several FSMA enactment dates that were poorly placed, and that the FDA would concentrate on creating a practical program. Taylor discussed how the FDA would be publishing preventive control guidance documents to help industry adapt to the new requirements. FDA inspections will be changing to accommodate the additional requirements of the prevention systems and food safety plan, which will require the agency to have increased access to company records.